TEL AVIV Jan 21 Pluristem Therapeutics Inc
said results from its early/mid-stage clinical trial
indicated its placenta-derived stem cells for the treatment of
muscle injury were safe and provided evidence the cells might be
effective in treating orthopedic injuries.
"Patients treated with PLX-PAD had a greater improved change
of maximal voluntary muscle contraction force than the placebo
group," Israel-based Pluristem said in a statement on
The trial was conducted at the Orthopedic Clinic of the
Charite University Medical School under the auspices of the
Paul-Ehrlich-Institute, Germany's health authority.
"This was a very important study not only for Pluristem but
for the cell therapy industry in general," Pluristem chief
executive Zami Aberman said. "Based on these results, we intend
to move forward with implementing our strategy towards using PLX
cells in orthopedic indications and muscle trauma."
The injured muscle studied was the gluteus medius muscle in
the buttock. Total hip replacement surgery via the standard
transgluteal approach necessitates injury of the gluteus medius
muscle, and post-operative healing is crucial for joint
stability and function.
"The study showed that PLX-PAD cells were safe and well
tolerated," the statement said.
The primary efficacy endpoint of the study was the change in
maximal voluntary isometric contraction force of the gluteal
muscle six months after surgery.
Efficacy was shown in two groups treated with the cells,
with one group receiving a 150 million cell dose displaying a
500 percent improvement over the placebo group. Patients treated
with a 300 million cell dose showed a 300 percent improvement
over the placebo.
An analysis of the gluteal muscle indicated an increase in
muscle volume in those patients treated with PLX-PAD cells
versus the placebo group.